MAUDE Adverse Event Report: COOK ENDOSCOPY TRACER METRO DIRECT WIRE GUIDE; OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY

Catalog Number METII-35-480

Device Problem Entrapment of Device (1212)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2022

Event Type  Injury  

Event Description

During an endoscopic procedure, the physician used a cook tracer metro direct wire guide.It was reported that that the tip of a guidewire was "broken accidentally due to space between metallic stent." a ct (computerized tomography) scan was conducted and showed that most of the retained part of guidewire was inside lumen of metallic stent.An ercp (endoscopic retrograde cholangiopancreatography) was conducted to retrieve the retained part.According to the initial reporter a section of the device did not remain inside the patient¿s body.The detached portions were retrieved via ercp.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

Investigation evaluation: our laboratory evaluation of the customer-supplied images and the product said to be involved confirmed the report.The first customer image shows a wire guide in a pouch, the tip of the wire guide is not present and the shrink tube appeared empty.The second image shows a wire guide tip contained in a glass jar, the tip contains both wire and shrink tube.A visual inspection of the wire guide was performed and the distal tip of the device appears to have been damaged due to the pre-placed stent.The distal tip of the wire guide detached and also returned for evaluation.It measured approximately 6.8cm in length.A section of the coating approximately 3.8cm long is frayed and hanging from the detached piece of wire guide, but the coating still attached at approximately 3.0cm from the distal end.The wire guide itself, contained a section of wire guide approximately 3.0cm in length at the distal tip, that did not contain core wire.The total length of the device was measured to be approximately 470.8cm plus the detached 6.8cm section of the wire guide.This brings the total projected length to 477.6cm therefore no other section appears to be missing.A product-specific discrepancy that could have caused or contributed to this observation was not observed during our laboratory analysis.The device history record for the lot number said to be involved was reviewed.A discrepancy or anomaly was not observed with the product that was released for distribution.Investigation conclusion: a definitive cause for the reported observation could not be determined because the condition of the product said to be involved prohibited a complete evaluation, however the condition of the device supports the customer report of breakage due to being caught on a stent.Prior to distribution, all tracer metro direct wire guides are subjected to a visual inspection and functional test to ensure device integrity.A review of the device history record confirmed that the lot said to be involved met all manufacturing requirements prior to shipment.Corrective action: a review of the complaint history was conducted and this represents an isolated occurrence.The likelihood of occurrence is considered remote.Corrective action is not warranted at this time based on the quality engineering risk assessment.Quality assurance will continue to monitor for complaint trends and reassess the risk assessment results as post market feedback continues to become available.

• Brand Name: TRACER METRO DIRECT WIRE GUIDE
• Type of Device: OCY ENDOSCOPIC GUIDEWIRE, GASTROENTEROLOGY-UROLOGY
• Manufacturer (Section D): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer (Section G): COOK ENDOSCOPY; 4900 bethania station rd; winston-salem NC 27105
• Manufacturer Contact: sabrina o'brien ; 4900 bethania station rd; winston-salem, NC 27105 ; 3367440157
• MDR Report Key: 13523971
• MDR Text Key: 286445707
• Report Number: 1037905-2022-00059
• Device Sequence Number: 1
• Product Code: OCY
• UDI-Device Identifier: 10827002256863
• UDI-Public: (01)10827002256863(17)230421(10)W4342370
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/21/2023
• Device Catalogue Number: METII-35-480
• Device Lot Number: W4342370
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Initial Date Manufacturer Received: 01/18/2022
• Initial Date FDA Received: 02/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/21/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: OLYMPUS GIF2T240 ENDOSCOPE
• Patient Outcome(s): Required Intervention